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posaconazole 18 mg/mL Solution, 1 vial — NDC 67457-665-20 (Billing 67457-0665-20)

by Mylan Institutional LLC · 1 VIAL, GLASS in 1 CARTON / 16.7 mL in 1 VIAL, GLASS

This is a package of 1 vial of posaconazole 18 mg/mL Solution from Mylan Institutional LLC, marketed since Mar 2024 and currently FDA-listed. It is this product's only package size.

NDC 67457-0665-20
🏷️ FDA NDC (as labeled) 67457-665-20 billing pads the product segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Aug 13, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 67457-665-20 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
67457 labeler · 665 product · 20 package
Package marketed since
Mar 22, 2024
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 6745766520 7
FDA record last changed
Aug 13, 2026
⚠️
Other active recalls for Posaconazole (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Dec 12, 2025 — Presence of particulate matter: potential presence of metal particulates in the product. (Merck Sharp & Dohme LLC) · FDA recall D-0242-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 67457-665-20
Product NDC 67457-665
11-digit billing NDC 67457066520
NCPDP billing unit ML — per mL (volume)
RxCUI 1492043
UNII 6TK1G07BHZ
Application # ANDA211500
SPL Set ID 1ebbd88b-547b-4b49-ab73-98094a2d5a79
Established class (EPC) Azole Antifungal
Chemical class Azoles
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-03-22
Route INTRAVENOUS
Dosage form SOLUTION
Substance POSACONAZOLE
TE code (Orange Book) AP · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 072141
GCN 36248
HICL code 033461
Ingredient (HICL) Posaconazole
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W3
Therapeutic class — intermediate (HIC2) Antimycotics
HIC3 code W3B
Therapeutic class — specific (HIC3) Antifungal Agents
AHFS code 08:14.08.00
AHFS class Azole Antifungals
FDB label name POSACONAZOLE 300 MG/16.7 ML VL
FDB brand name Posaconazole
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 072141
  • GCN: 36248
  • HICL (First Databank): 033461
  • AHFS class code: 08:14.08.00
  • RxCUI (RxNorm): 1492043
Why two NDCs? The FDA registers this code as 67457-665-20 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 67457-0665-20. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Azole Antifungal class.

Pharmacologic class Azole Antifungal
Drug family (ATC) Triazole and tetrazole derivatives
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name POSACONAZOLE 300 MG/16.7 ML VL Ingredient Posaconazole
📖 What it is MedlinePlus · NLM

Posaconazole injection is used to prevent serious fungal infections that can spread throughout the body in adults and children 2 years of age and older with a weakened ability to fight infection. Posaconazole injection is also used to treat invasive aspergillosis (a serious fungal infection that begins in the lungs and spreads through the bloodstream to other organs) in adults and teenagers 13 years of age and older. Posaconazole injection is in a class of medications called azole antifungals. It works by slowing the growth of fungi that cause infection.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It treats invasive aspergillosis, a serious mold infection. It also helps prevent serious Aspergillus and Candida infections when your immune system is severely weakened. The oral...
  • Delayed-release tablets can be taken with or without food. The oral suspension should be taken with a full meal. The injection is given by a clinician through a central line over a...
  • The most common are diarrhea, nausea, vomiting, fever, headache, cough and low potassium. Let your care team know if they are bothersome or severe.
  • Call right away for a racing or irregular heartbeat, fainting, signs of liver trouble, rising blood pressure or swelling, or severe vomiting and diarrhea. Those last two can keep t...
📖 Read our full Posaconazole guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · J1837 $0.342 / J1837 unit —
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Billing & reimbursement

FDA NDC (as labeled)67457-665-20
11-digit billing NDC67457-0665-20
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ1837
DescriptorINJECTION, POSACONAZOLE, 1 MG
Billing units / pkg18 units
How the units are derivedThis package is 16.7 ML; the HCPCS unit is 1 MG, so one package = 18 billing units.
Medicare Part B spend (2026 (Q1))$1,227 · 12 claims · $102.28 per claim (all NDCs under J1837)
Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
67457-0665-20 You're viewing this Main listing 1 VIAL, GLASS in 1 CARTON / 16.7 mL in 1 VIAL, GLASS 2024-03-22 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Noxafil 18 mg/mL 00085-4331-01 Merck 1 vial — — FDA listed —
Posaconazole 18 mg/mL 31722-0370-31 Camber 1 vial — AP FDA listed —
Posaconazole 18 mg/mL 42023-0195-01 Par 1 vial — AP FDA listed —
Posaconazole 18 mg/mL 55150-0388-01 Eugia 1 vial — AP FDA listed —
Posaconazole 18 mg/mL 63323-0685-17 Fresensius 1 vial — AP FDA listed —
posaconazole 18 mg/mLthis 67457-0665-20 Mylan 1 vial — AP FDA listed —
posaconazole 18 mg/mL 68083-0577-01 Gland 1 vial — AP FDA listed —
posaconazole 18 mg/mL 68462-0904-01 GLENMARK 1 vial — AP FDA listed —
posaconazole 18 mg/mL 68462-0911-01 GLENMARK 1 vial — AP FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2024
On the market since
Mar 2024
📍
2026
Currently FDA-listed
2 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerMylan Institutional LLC
Application holderMYLAN LABORATORIES LTD
FDA applicationANDA211500 (ANDA)
Labeler code67457
First marketedMar 2024
Product typeHuman Prescription Drug
Portfolio167 products on file

More NDCs from Mylan Institutional LLC labeler code 67457

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage ~1 min read ▾

1 INDICATIONS AND USAGE Posaconazole is an azole antifungal indicated as follows: • Posaconazole is indicated for the treatment of invasive aspergillosis as follows: ( 1.1 ) o Posaconazole injection : adults and pediatric patients 2 years of age and older who weigh 10 kg or greater. • Posaconazole is indicated for the prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy as follows: ( 1.2 ) o Posaconazole injection : adults and pediatric patients 2 years of age and older who weigh 10 kg or greater.

1.1Treatment of Invasive Aspergillosis Posaconazole injection is indicated for the treatment of invasive aspergillosis as follows : • Posaconazole injection: adults and pediatric patients 2 years of age and older who weigh 10 kg or greater

1.2Prophylaxis of Invasive Aspergillus and Candida Infections Posaconazole injection is indicated for the prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy as follows: • Posaconazole injection: adults and pediatric patients 2 years of age and older who weigh 10 kg or grea ter

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION • Posaconazole injection must be administered through an in-line filter. ( 2.6 ) • Administer posaconazole injection by intravenous infusion over approximately 90 minutes via a central venous line. ( 2.1 , 2.6 ) • Do NOT administer posaconazole injection as an intravenous bolus injection.

( 2.1 ) • See the full prescribing information for important administration instructions and preparation instructions for posaconazole injection ( 2.5 , 2.6 ) • For adult and pediatric patients aged 2 years of age and older, see the Full Prescribing Information for dosing recommendations for posaconazole injection based on the indication, age, and weight associated with the dosage form ( 1.1 , 1.2 , 2.1 , 2.2 , 2.3 )

2.1Important Administration Instructions Posaconazole injection • Administer via a central venous line, including a central venous catheter or peripherally inserted central catheter (PICC), by slow intravenous infusion over approximately 90 minutes [see Dosage and Administration (2.6) ] . • Do NOT administer posaconazole injection as an intravenous bolus injection .

2.2Recommended Dosage of Posaconazole Injection in Adult Patients The recommended dosage of posaconazole injection in adult patients for the treatment of invasive aspergillosis, prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised is shown in Table 1 [see Dosage and Administration (2.5 , 2.6) and Clinical Pharmacology (12.3) ] . Table 1: Recommended Dosage of Posaconazole Injection in Adult Patients Dosage Duration of Therapy Treatment of Invasive Aspergillosis Switching between the posaconazole injection and delayed-release tablets is acceptable.

A loading dose is not required when switching between dosage forms. Posaconazole Injection: Loading dose : 300 mg posaconazole injection intravenously twice a day on the first day. Maintenance dose : 300 mg posaconazole injection intravenously once a day, starting on the second day.

Loading dose : 1 day Maintenance dose : Recommended total duration of therapy is 6 to 12 weeks. Prophylaxis of Invasive Aspergillus and Candida Infections Posaconazole Injection: Loading dose : 300 mg posaconazole injection intravenously twice a day on the first day. Maintenance dose : 300 mg posaconazole injection intravenously once a day thereafter.

Loading dose : 1 day Maintenance dose : Duration of therapy is based on recovery from neutropenia or immunosuppression.

2.3Recommended Dosage of Posaconazole Injection for the Treatment of Invasive Aspergillosis and Prophylaxis of Invasive Aspergillus and Candida Infections in Pediatric Patients 2 Years of Age and Older Posaconazole injection The recommended dosage of posaconazole injection in pediatric patients 2 years of age and older who weigh 10 kg or greater for the treatment of invasive aspergillosis and prophylaxis of invasive Aspergillus and Candida infections is shown in Table 2 [see Dosage and Administration (2.5 , 2.6 ) and Clinical Pharmacology (12.3) ] .

Table 2: Recommended Dosage of Posaconazole Injection for the Treatment of Invasive Aspergillosis Switching between the intravenous and delayed-release tablets is acceptable. A loading dose is not required when switching between formulations . and Prophylaxis of Invasive Aspergillus and Candida Infections in Pediatric Patients (2 Years of Age and Older) Recommended Pediatric Dosage by Formulatio n Duration of Therapy Posaconazole Injection (patients weighing 10 kg or greater ): Loading dose : 6 mg/kg up to a maximum of 300 mg twice daily on the first da y Maintenance dose : 6 mg/kg up to a maximum of 300 mg once daily, starting on the second day .

Treatment of invasive aspergillosis : Recommended total duration of therapy is 6 to 12 weeks. Prophylaxis of invasive Aspergillus and Candida infections: Duration of therapy is based on recovery from neutropenia or immunosuppression.

2.5Preparation of Po… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 43 words ▾

3 DOSAGE FORMS AND STRENGTHS Posaconazole injection Posaconazole injection 300 mg/16.7 mL (18 mg/mL) is available as a clear, colorless to yellow sterile liquid in a single-dose vial. • Posaconazole injection: 300 mg/16.7 mL (18 mg/mL) in a single-dose vial ( 3 )

⛔ Contraindications ~2 min read ▾

4 CONTRAINDICATIONS • Known hypersensitivity to posaconazole or other azole antifungal agents. ( 4.1 ) • Coadministration of posaconazole with the following drugs is contraindicated; posaconazole increases concentrations and toxicities of: • Sirolimus: ( 4.2 , 7.2 ) • CYP3A4 substrates (pimozide, quinidine): can result in QTc interval prolongation and cases of torsades de pointes (TdP) ( 4.3 , 5.2 , 7.2 ) • HMG-CoA Reductase Inhibitors Primarily Metabolized through CYP3A4 ( 4.4 , 7.2 ) • Ergot alkaloids ( 4.5 , 7.2 ) • Venetoclax: In patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) at initiation and during the ramp-up phase ( 4.6 , 5.11 , 7.2 )

4.1Hypersensitivity Posaconazole is contraindicated in persons with known hypersensitivity to posaconazole or other azole antifungal agents.

4.2Use with Sirolimus Posaconazole is contraindicated with sirolimus. Concomitant administration of posaconazole with sirolimus increases the sirolimus blood concentrations by approximately 9-fold and can result in sirolimus toxicity [see Drug Interactions (7.2) and Clinical Pharmacology (12.3) ] .

4.3QT Prolongation with Concomitant Use with CYP3A4 Substrates Posaconazole is contraindicated with CYP3A4 substrates that prolong the QT interval. Concomitant administration of posaconazole with the CYP3A4 substrates, pimozide and quinidine may result in increased plasma concentrations of these drugs, leading to QTc prolongation and cases of torsades de pointes [see Warnings and Precautions (5.2) and Drug Interactions (7.2) ] .

4.4HMG-CoA Reductase Inhibitors Primarily Metabolized Through CYP3A4 Coadministration with the HMG-CoA reductase inhibitors that are primarily metabolized through CYP3A4 (e.g., atorvastatin, lovastatin, and simvastatin) is contraindicated since increased plasma concentration of these drugs can lead to rhabdomyolysis [see Drug Interactions (7.2) and Clinical Pharmacology (12.3) ] .

4.5Use with Ergot Alkaloids Posaconazole may increase the plasma concentrations of ergot alkaloids (ergotamine and dihydroergotamine) which may lead to ergotism [see Drug Interactions (7.2) ] .

4.6Use with Venetoclax Coadministration of posaconazole with venetoclax at initiation and during the ramp-up phase is contraindicated in patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) due to the potential for increased risk of tumor lysis syndrome [see Warnings and Precautions (5.11) and Drug Interactions (7.2) ] .

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS • Calcineurin-Inhibitor Toxicity : Posaconazole increases concentrations of cyclosporine or tacrolimus; reduce dose of cyclosporine and tacrolimus and monitor concentrations frequently. ( 5.1 ) • Arrhythmias and QTc Prolongation : Posaconazole has been shown to prolong the QTc interval and cause cases of TdP. Administer with caution to patients with potentially proarrhythmic conditions.

Do not administer with drugs known to prolong QTc interval and metabolized through CYP3A4. ( 5.2 , 7.2 ) • Electrolyte Disturbances : Monitor and correct, especially those involving potassium (K + ), magnesium (Mg ++ ), and calcium (Ca ++ ), before and during posaconazole therapy. ( 5.3 ) • Pseudoaldosteronism : Manifested by the onset or worsening of hypertension, and abnormal laboratory findings.

Monitor blood pressure and potassium levels, and manage as necessary. ( 5.4 ) • Hepatic Toxicity : Elevations in liver tests may occur. Discontinuation should be considered in patients who develop abnormal liver tests or monitor liver tests during treatment.

( 5.5 ) • Renal Impairment : Posaconazole injection should be avoided in patients with moderate or severe renal impairment (eGRF less than 50 mL/min1.73m 2 ), unless an assessment of the benefit/risk to the patient justifies the use of posaconazole injection. ( 5.6 , 8.6 ) • Concomitant Use with Midazolam : Posaconazole can prolong hypnotic/sedative effects. Monitor patients and benzodiazepine receptor antagonists should be available.

( 5.7 , 7.2 ) • Vincristine Toxicity : Concomitant administration of azole antifungals, including posaconazole, with vincristine has been associated with neurotoxicity and other serious adverse reactions; reserve azole antifungals, including posaconazole, for patients receiving a vinca alkaloid, including vincristine, who have no alternative antifungal treatment options. ( 5.8 , 7.2 ) • Venetoclax Toxicity : Concomitant administration of posaconazole with venetoclax may increase venetoclax toxicities, including the risk of tumor lysis syndrome, neutropenia, and serious infections; monitor for toxicity and reduce venetoclax dose.

( 4.6 , 5.11 , 7.2 )

5.1Calcineurin-Inhibitor Toxicity Concomitant administration of posaconazole with cyclosporine or tacrolimus increases the whole blood trough concentrations of these calcineurin-inhibitors [see Drug Interactions (7.2) and Clinical Pharmacology (12.3) ] . Nephrotoxicity and leukoencephalopathy (including deaths) have been reported in clinical efficacy studies in patients with elevated cyclosporine or tacrolimus concentrations. Frequent monitoring of tacrolimus or cyclosporine whole blood trough concentrations should be performed during and at discontinuation of posaconazole treatment and the tacrolimus or cyclosporine dose adjusted accordingly.

5.2Arrhythmias and QT Prolongation Some azoles, including posaconazole, have been associated with prolongation of the QT interval on the electrocardiogram. In addition, cases of torsades de pointes have been reported in patients taking posaconazole. Results from a multiple time-matched ECG analysis in healthy volunteers did not show any increase in the mean of the QTc interval.

Multiple, time-matched ECGs collected over a 12-hour period were recorded at baseline and steady-state from 173 healthy male and female volunteers (18-85 years of age) administered Noxafil ® oral suspension 400 mg twice daily with a high-fat meal. In this pooled analysis, the mean QTc (Fridericia) interval change from baseline was –5 msec following administration of the recommended clinical dose. A decrease in the QTc(F) interval (–3 msec) was also observed in a small number of subjects (n=16) administered placebo.

The placebo-adjusted mean maximum QTc(F) interval change from baseline was <0 msec (–8 msec). No healthy subject administered posaconazole had a QTc(F) interval ≥500 msec or an increase ≥60 msec in their QTc(F) interval from baseline. Posaconazole should be administere… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following serious and otherwise important adverse reactions are discussed in detail in another section of the labeling: • Arrhythmias and QT Prolongation [see Warnings and Precautions (5.2) ] • Electrolyte and Disturbances [see Warnings and Precautions (5.3) ] • Pseudoaldosteronism [see Warnings and Precautions (5.4) ] • Hepatic Toxicity [see Warnings and Precautions (5.5) ] • Adult Patients: Common adverse reactions in studies with posaconazole in adults are diarrhea, nausea, fever, vomiting, headache, coughing, and hypokalemia.

( 6.1 ) • Pediatric Patients: Common adverse reactions (incidence >20% receiving 6 mg/kg posaconazole injection) in a study in pediatric patients are pyrexia, febrile neutropenia, vomiting, mucosal inflammation, pruritus, hypertension, hypokalemia, and stomatitis. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Mylan at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of posaconazole cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Treatment of Invasive Aspergillosis in Adults and Adolescents (Posaconazole Injection and Noxafil Delayed-Release Tablets) The safety of posaconazole injection and Noxafil delayed-release tablets was assessed in a randomized, double-blind, active-controlled clinical study of posaconazole injection and Noxafil delayed-release tablets versus voriconazole for treatment of invasive aspergillosis (Aspergillosis Treatment Study).

A total of 575 adult and pediatric patients 14 years of age and older (288 in posaconazole group, 287 in voriconazole group (voriconazole for injection or voriconazole tablets)) with proven, probable or possible invasive aspergillosis were included. The median duration of treatment was 67 days for posaconazole injection or Noxafil delayed-release tablets and 64 days for voriconazole. In this study, 55% to 60% of patients started intravenous treatment with posaconazole injection or voriconazole (voriconazole injection).

The median duration of the first instance of intravenous treatment (before switching to oral treatment or discontinuing or completing study treatment) was 9 days for both groups. Table 7 presents adverse reactions reported at an incidence of ≥ 10% in either one of the treatment groups in Aspergillosis Treatment Study. Adverse reactions leading to treatment discontinuation were reported for 34% of patients.

The most commonly reported adverse reactions (> 2% of patients) leading to treatment discontinuation were septic shock, respiratory failure, and bronchopulmonary aspergillosis in the posaconazole group, and septic shock and acute myeloid leukemia in the voriconazole group. The most frequently reported adverse reactions in the posaconazole-treated group were pyrexia (28%), hypokalemia (28%), and nausea (23%). Table 7: Adverse Reactions in at Least 10% of Adults and Adolescents Receiving Posaconazole Injection or Noxafil Delayed-Release Tablets for the Treatment of Invasive Aspergillosis Adverse Reactions Posaconazole injection or Noxafil delayed-release tablets (n = 288) (%) Voriconazole for injection or Voriconazole tablets (n = 287) (%) Percentage of Patients Reporting any Adverse Reaction 97.6

97.6Hypokalemia 28.5

17.1Pyrexia 28.1

25.1Nausea 22.6

17.8Diarrhea 18.1

18.1Vomiting 18.1

13.6Alanine aminotransferase increased 14.6

12.9Febrile neutropenia 14.6

13.2Aspartate aminotransferase increased 13.2

12.5Pneumonia 12.5

9.1Headache 12.2

8.7Constipation 11.1

8.0Edema peripheral 11.1

8.4Epistaxis 11.1

5.9Cough 10.4

8.4Abdominal pain 10.1

8.4Hypomagnesemia 10.1

6.3Clinical Trial Experience with Posaconazole Injection for Prophylaxis of Invasive Aspergillus and Candida Infections Administration of multiple doses of posaconazole inject… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS Table 15 and Table 17 include drugs with clinically important drug interactions when administered concomitantly with posaconazole and instructions for preventing or managing them. These recommendations are based on either drug interaction studies or predicted interactions due to the expected magnitude of interaction and potential for serious adverse reactions or loss of efficacy [see Clinical Pharmacology (12.3) ] . The following information was derived from data with Noxafil oral suspension or another posaconazole tablet formulation unless otherwise noted.

All clinically important drug interactions with Noxafil oral suspension, except for those that affect the absorption of posaconazole (via gastric pH and motility), are considered relevant to clinically important drug interactions with posaconazole injection. Consult the labeling of concomitantly used drugs to obtain further information about interactions with posaconazole. Interaction Drug Interaction Rifabutin, phenytoin, efavirenz Avoid coadministration unless the benefit outweighs the risks ( 7.1 , 7.2 ) Other drugs metabolized by CYP3A4 Consider dosage adjustment and monitor for adverse effects and toxicity ( 7.2 ) Digoxin Monitor digoxin plasma concentrations ( 7.2 ) Fosamprenavir Monitor for breakthrough fungal infections ( 7.1 )

7.1Effects of Other Drugs on Posaconazole Posaconazole is primarily metabolized via UDP-glucuronosyltransferase and is a substrate of p-glycoprotein (P-gp) efflux. Therefore, inhibitors or inducers of these clearance pathways may affect posaconazole plasma concentrations. Concomitant use of posaconazole with drugs that can decrease the plasma posaconazole concentrations should generally be avoided unless the benefit outweighs the risk.

If such drugs are necessary, patients should be monitored closely for breakthrough fungal infections. Table 15: Drug Interactions Affecting Posaconazole When Administered Concomitantly with Other Drugs UDP-Glucuronidase Inducers Mechanism and Clinical Effect(s) Posaconazole is a UDP-glucuronosyltransferase substrate. Concomitant use of posaconazole with UDP-glucuronidase inducers may decrease posaconazole exposure [see Clinical Pharmacology (12.3) ], which may reduce the effectiveness of posaconazole.

Prevention or Management Efavirenz Avoid concomitant use of posaconazole with efavirenz, unless the benefit outweighs the risks. Rifabutin Avoid concomitant use of posaconazole with rifabutin unless the benefit to the patient outweighs the risk. If concomitant use is needed, monitor closely for breakthrough fungal infections.

See Table 17 for rifabutin monitoring considerations when posaconazole affects rifabutin via CYP3A4 inhibition. Phenytoin Avoid concomitant use of posaconazole with phenytoin unless the benefit to the patient outweighs the risk. If concomitant use is needed, monitor for breakthrough fungal infections.

See Table 17 for phenytoin monitoring considerations when posaconazole affects phenytoin via CYP3A4 inhibition. Fosamprenavir Mechanism and Clinical Effect(s) Concomitant use of posaconazole with fosamprenavir may lead to decreased posaconazole plasma concentrations [see Clinical Pharmacology (12.3) ], which may reduce effectiveness of posaconazole. Prevention or Management If concomitant use of posaconazole with fosamprenavir is needed, monitor closely for breakthrough fungal infections.

7.2Effects of Posaconazole on Other Drugs Posaconazole is a strong CYP3A4 inhibitor. Therefore, concomitant use of posaconazole may increase plasma concentrations of drugs that are CYP3A4 substrates [see Clinical Pharmacology (12.3) ] . Table 17: Drug Interactions Affecting Drugs Administered Concomitantly with Posaconazole Digoxin Clinical Effect(s) Increased digoxin plasma concentrations have been reported in patients who received concomitant posaconazole and digoxin.

Prevention or Management Monitor digoxin plasma concentrations during concomitant use of posaconazole. Glipizide Clinical… [Excerpted — this section continues on DailyMed.]

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS • Pregnancy: Based on animal data, may cause fetal harm. ( 8.1 ) • Pediatrics: Safety and effectiveness in patients younger than 2 years of age have not been established. ( 8.4 ) • Severe Renal Impairment: Monitor closely for breakthrough fungal infections. ( 8.6 )

8.1Pregnancy Risk Summary Based on findings from animal data, posaconazole may cause fetal harm when administered to pregnant women. Available data for use of posaconazole in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies, skeletal malformations were observed when posaconazole was dosed orally to pregnant rats during organogenesis at doses ≥ 1.4 times the 400 mg twice daily oral suspension regimen based on steady-state plasma concentrations of posaconazole in healthy volunteers.

In pregnant rabbits dosed orally during organogenesis, doses of ≥ 3 times the clinical exposure caused an increase in resorptions (see Data ) . Based on animal data, advise pregnant women of the potential risk to a fetus. The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data Posaconazole resulted in maternal toxicity (reduced food consumption and reduced body weight gain) and skeletal malformations (cranial malformations and missing ribs) when given orally to pregnant rats during organogenesis (Gestational Days 6 through 15) at doses ≥27 mg/kg (≥1.4 times the 400 mg twice daily oral suspension regimen based on steady-state plasma concentrations of drug in healthy volunteers).

The no-effect dose for malformations and maternal toxicity in rats was 9 mg/kg, which is 0.7 times the exposure achieved with the 400 mg twice daily oral suspension regimen. No malformations were seen in rabbits dosed during organogenesis (Gestational Days 7 through 19) at doses up to 80 mg/kg (5 times the exposure achieved with the 400 mg twice daily oral suspension regimen). In the rabbit, the no-effect dose was 20 mg/kg, while high doses of 40 mg/kg and 80 mg/kg (3 or 5 times the clinical exposure) caused an increase in resorptions.

In rabbits dosed at 80 mg/kg, a reduction in body weight gain of females and a reduction in litter size were seen.

8.2Lactation Risk Summary There are no data on the presence of posaconazole in human milk, the effects on the breastfed infant, or the effects on milk production. Posaconazole is excreted in the milk of lactating rats. When a drug is present in animal milk, it is likely that the drug will be present in human milk.

The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for posaconazole and any potential adverse effects on the breastfed child from posaconazole or from the underlying maternal condition.

8.4Pediatric Use Treatment of Invasive Aspergillosis The safety and effectiveness of posaconazole injection have been established for the treatment of invasive aspergillosis in pediatric patients 2 years of age and older. Use of posaconazole for these pediatric indications is supported by evidence from adequate and well-controlled studies of posaconazole in adults and safety and pharmacokinetic (PK) data from two pediatric studies [see Adverse Reactions (6.1) and Clinical Pharmacology (12.3) ] . The safety of posaconazole in pediatric patients for these pediatric indications was consistent with the known safety profile of posaconazole in adults [see Adverse Reactions (6.1) ] .

The safety and effectiveness of posaconazole have not been established in pediatric patients less than 2 years of age . Prophylaxis of Invasive Aspergillus… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary Based on findings from animal data, posaconazole may cause fetal harm when administered to pregnant women. Available data for use of posaconazole in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies, skeletal malformations were observed when posaconazole was dosed orally to pregnant rats during organogenesis at doses ≥ 1.4 times the 400 mg twice daily oral suspension regimen based on steady-state plasma concentrations of posaconazole in healthy volunteers.

In pregnant rabbits dosed orally during organogenesis, doses of ≥ 3 times the clinical exposure caused an increase in resorptions (see Data ) . Based on animal data, advise pregnant women of the potential risk to a fetus. The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data Posaconazole resulted in maternal toxicity (reduced food consumption and reduced body weight gain) and skeletal malformations (cranial malformations and missing ribs) when given orally to pregnant rats during organogenesis (Gestational Days 6 through 15) at doses ≥27 mg/kg (≥1.4 times the 400 mg twice daily oral suspension regimen based on steady-state plasma concentrations of drug in healthy volunteers).

The no-effect dose for malformations and maternal toxicity in rats was 9 mg/kg, which is 0.7 times the exposure achieved with the 400 mg twice daily oral suspension regimen. No malformations were seen in rabbits dosed during organogenesis (Gestational Days 7 through 19) at doses up to 80 mg/kg (5 times the exposure achieved with the 400 mg twice daily oral suspension regimen). In the rabbit, the no-effect dose was 20 mg/kg, while high doses of 40 mg/kg and 80 mg/kg (3 or 5 times the clinical exposure) caused an increase in resorptions.

In rabbits dosed at 80 mg/kg, a reduction in body weight gain of females and a reduction in litter size were seen.

🧒 Pediatric Use ~1 min read ▾

8.4Pediatric Use Treatment of Invasive Aspergillosis The safety and effectiveness of posaconazole injection have been established for the treatment of invasive aspergillosis in pediatric patients 2 years of age and older. Use of posaconazole for these pediatric indications is supported by evidence from adequate and well-controlled studies of posaconazole in adults and safety and pharmacokinetic (PK) data from two pediatric studies [see Adverse Reactions (6.1) and Clinical Pharmacology (12.3) ] . The safety of posaconazole in pediatric patients for these pediatric indications was consistent with the known safety profile of posaconazole in adults [see Adverse Reactions (6.1) ] .

The safety and effectiveness of posaconazole have not been established in pediatric patients less than 2 years of age . Prophylaxis of Invasive Aspergillus and Candida Infections The safety and effectiveness of posaconazole injection have been established for the prophylaxis of invasive Aspergillus and Candida infections in pediatric patients 2 years of age and older who are at high risk of developing these infections due to being severely immunocompromised. Use of posaconazole for these pediatric indications is supported by adequate and well controlled studies of posaconazole in adults and pediatric patients aged 13 years of age and older and additional PK and safety data in pediatric patients 2 years of age and older [see Clinical Pharmacology (12.3) and Clinical studies (14) ] .

Treatment of Oropharyngeal Candidiasis, including Refractory to Itraconazole and/or Fluconazole Posaconazole injection is not approved for the treatment of oropharyngeal candidiasis in pediatric patients. The safety and effectiveness of posaconazole have not been established in pediatric patients less than 2 years of age.

🧓 Geriatric Use 140 words ▾

8.5Geriatric Use No overall differences in the safety or effectiveness of posaconazole injection have been observed between geriatric patients and younger adult patients in the clinical trials; therefore, the recommended dosage in geriatric patients is the same as that for younger adult patients. No clinically meaningful differences in posaconazole pharmacokinetics were observed in posaconazole-treated geriatric patients compared to posaconazole-treated younger adult patients during clinical trials [see Clinical Pharmacology (12.3) ] . • Of the 279 patients treated with posaconazole injection in the Posaconazole Injection Study (prophylaxis of invasive Aspergillus and Candida infections in those at high risk of developing these infections due to be ing severly immunocompromised, 52 (19%) patients were > 65 years of age. • Of the 288 patients treated with posaconazole injection in the Aspergillosis Treatment Study, 85 (29%) patients were ≥ 65 years of age.

🆘 Overdosage 17 words ▾

10 OVERDOSAGE There is no experience with overdosage of posaconazole injection. Posaconazole is not removed by hemodialysis.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Posaconazole is an azole antifungal agent [see Clinical Pharmacology (12.4) ] .

12.2Pharmacodynamics Exposure Response Relationship: Treatment of Invasive Aspergillosis in Adult and Adolescent Patients Across a range of posaconazole plasma minimum concentrations (C min , range: 244 to 5663 ng/mL) following administration of posaconazole injection and Noxafil delayed-release tablets in adult and pediatric patients aged 14 years and older treated for invasive aspergillosis in Aspergillosis Treatment Study, there was no association between posaconazole C min and treatment efficacy [see Clinical Pharmacology (12.3) and Clinical Studies (14.1) ] .

Similarly, across a range of population pharmacokinetic model-predicted steady-state plasma average concentrations (C avg , range: 589 to 6315 ng/mL), there was no association between posaconazole C avg and treatment efficacy.

12.3Pharmacokinetics General Pharmacokinetic Characteristics General Pharmacokinetic Characteristics of Posaconazole Injection Posaconazole injection exhibits dose proportional pharmacokinetics after single doses between 200 and 300 mg in healthy volunteers and patients. The mean pharmacokinetic parameters after single doses with posaconazole injection in healthy volunteers and patients are shown in Table 19. Table 19: Summary of Mean Pharmacokinetic Parameters (%CV) in Healthy Volunteers (30 minute infusion via peripheral venous line) and Patients (90 minute infusion via central venous line) after Dosing with Posaconazole Injection on Day 1 Dose (mg) n AUC 0-∞ (ng∙hr/mL) AUC 0-12 (ng∙hr/mL) C max (ng/mL) t 1/2 (hr) CL (L/hr) AUC 0-∞ = Area under the plasma concentration-time curve from time zero to infinity; AUC 0-12 = Area under the plasma concentration-time curve from time zero to 12 hr after the first dose on Day 1; C max = maximum observed concentration; t ½ = terminal phase half-life; CL = total body clearance; N/D = Not Determined Healthy Volunteers 200 9 35400 (50) 8840 (20) 2250 (29) 23.6 (23) 6.5 (32) 300 9 46400 (26) 13000 (13) 2840 (30) 24.6 (20) 6.9 (27) Patients 200 30 N/D 5570 (32) 954 (44) N/D N/D 300 22 N/D 8240 (26) 1590 (62) N/D N/D Table 20 displays the pharmacokinetic parameters of posaconazole in patients following administration of posaconazole injection 300 mg taken once a day for 10 or 14 days following twice daily dosing on Day 1.

Table 20: Arithmetic Mean (%CV) of PK Parameters in Serial PK-Evaluable Patients Following Dosing of Posaconazole Injection (300 mg) 300 mg dose administered over 90 minutes once a day following twice daily dosing on Day 1 AUC 0-24 = area under the concentration-time curve over the dosing interval (i.e., 24 hours); C av = time-averaged concentrations (i.e., AUC 0-24h /24hr); C min = POS trough level immediately before a subject received the dose of POS on the day specified in the protocol; C max = observed maximum plasma concentration; CV = coefficient of variation, expressed as a percent (%); Day = study day on treatment; T max = time of observed maximum plasma concentration.

Day N C max (ng/mL) T max Median (minimum-maximum) (hr) AUC 0-24 (ng * hr/mL) C av (ng/mL) C min (ng/mL) 10/14 49 3280 (74) 1.5 (0.98-4.0) 36100 (35) 1500 (35) 1090 (44) Distribution The mean volume of distribution of posaconazole after intravenous solution administration was 261 L and ranged from 226-295 L between studies and dose levels. Posaconazole is highly bound to human plasma proteins (> 98%), predominantly to albumin. Metabolism Posaconazole primarily circulates as the parent compound in plasma.

Of the circulating metabolites, the majority are glucuronide conjugates formed via UDP glucuronidation (phase 2 enzymes). Posaconazole does not have any major circulating oxidative (CYP450 mediated) metabolites. The excreted metabolites in urine and feces account for ~ 17% of the administered radiolabeled dose.

Posaconazole is a substrate for p-glycoprotein (P-gp) efflux. In vitro studies w… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 95 words ▾

12.1Mechanism of Action Posaconazole is an azole antifungal agent [see Clinical Pharmacology (12.4) ] .

Mechanism of Action Posaconazole blocks the synthesis of ergosterol, a key component of the fungal cell membrane, through the inhibition of cytochrome P-450 dependent enzyme lanosterol 14α-demethylase responsible for the conversion of lanosterol to ergosterol in the fungal cell membrane. This results in an accumulation of methylated sterol precursors and a depletion of ergosterol within the cell membrane thus weakening the structure and function of the fungal cell membrane. This may be responsible for the antifungal activity of posaconazole.

📦 How Supplied / Storage and Handling 93 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied Posaconazole Injection Posaconazole injection is a clear, colorless to yellow sterile liquid in single-dose Type I glass vials closed with bromobutyl rubber stopper and aluminum seal containing 300 mg of posaconazole in 16.7 mL of solution (18 mg of posaconazole per mL) (NDC 67457-665-20).

16.2Storage and Handling Posaconazole Injection Store posaconazole injection vial refrigerated at 2° to 8°C (36° to 46°F). Storage conditions for the diluted posaconazole solution are presented in another section of the prescribing information [see Dosage and Administration (2.5) ] .

📋 Description 148 words ▾

11 DESCRIPTION Posaconazole injection contains posaconazole, an azole antifungal agent. Posaconazole is designated chemically as 4-[4-[4-[4-[[ (3 R ,5 R )-5-(2,4-difluorophenyl)tetrahydro-5-(1 H -1,2,4-triazol-1ylmethyl)-3-furanyl]methoxy]phenyl]-1-piperazinyl]phenyl]-2-[(1 S ,2 S )-1-ethyl-2-hydroxypropyl]-2,4-dihydro-3 H -1,2,4-triazol-3-one with an empirical formula of C 37 H 42 F 2 N 8 O 4 and a molecular weight of 700.8. The chemical structure is: Posaconazole is a white to off-white color powder which is soluble in dichloromethane and practically insoluble in water.

Posaconazole Injection Posaconazole injection, for intravenous use, is a clear colorless to yellow colored solution, without preservatives sterile liquid essentially free of foreign matter. Each vial contains 300 mg of posaconazole and the following inactive ingredients: 6.68 g Betadex Sulfobutyl Ether Sodium (SBECD), 0.0033 g edetate disodium, hydrochloric acid and sodium hydroxide to adjust the pH to 2.6, and water for injection. Each 1 mL of posaconazole injection contains 30 mg of sodium.

Posaconazole Chemical Structure

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( Patient Information ). Drug Interactions Advise patients to inform their physician immediately if they: • develop severe diarrhea or vomiting. • are currently taking drugs that are known to prolong the QTc interval and are metabolized through CYP3A4. • are currently taking a cyclosporine or tacrolimus, or they notice swelling in an arm or leg or shortness of breath. • are taking other drugs or before they begin taking other drugs as certain drugs can decrease or increase the plasma concentrations of posaconazole.

Serious and Potentially Serious Adverse Reactions Advise patients to inform their physician immediately if they: • notice a change in heart rate or heart rhythm or have a heart condition or circulatory disease. Posaconazole can be administered with caution to patients with potentially proarrhythmic conditions. • are pregnant, plan to become pregnant, or are nursing. • have liver disease or develop itching, nausea or vomiting, their eyes or skin turn yellow, they feel more tired than usual or feel like they have the flu. • have ever had an allergic reaction to other antifungal medicines such as ketoconazole, fluconazole, itraconazole, or voriconazole.

The brands listed are trademarks of their respective owners. Manufactured for: Mylan Institutional LLC Morgantown, WV 26505 U.S.A. Manufactured by: Mylan Institutional Galway, Ireland Revised: 7/2026 MI:POSACIJ:RX

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics General Pharmacokinetic Characteristics General Pharmacokinetic Characteristics of Posaconazole Injection Posaconazole injection exhibits dose proportional pharmacokinetics after single doses between 200 and 300 mg in healthy volunteers and patients. The mean pharmacokinetic parameters after single doses with posaconazole injection in healthy volunteers and patients are shown in Table 19. Table 19: Summary of Mean Pharmacokinetic Parameters (%CV) in Healthy Volunteers (30 minute infusion via peripheral venous line) and Patients (90 minute infusion via central venous line) after Dosing with Posaconazole Injection on Day 1 Dose (mg) n AUC 0-∞ (ng∙hr/mL) AUC 0-12 (ng∙hr/mL) C max (ng/mL) t 1/2 (hr) CL (L/hr) AUC 0-∞ = Area under the plasma concentration-time curve from time zero to infinity; AUC 0-12 = Area under the plasma concentration-time curve from time zero to 12 hr after the first dose on Day 1; C max = maximum observed concentration; t ½ = terminal phase half-life; CL = total body clearance; N/D = Not Determined Healthy Volunteers 200 9 35400 (50) 8840 (20) 2250 (29) 23.6 (23) 6.5 (32) 300 9 46400 (26) 13000 (13) 2840 (30) 24.6 (20) 6.9 (27) Patients 200 30 N/D 5570 (32) 954 (44) N/D N/D 300 22 N/D 8240 (26) 1590 (62) N/D N/D Table 20 displays the pharmacokinetic parameters of posaconazole in patients following administration of posaconazole injection 300 mg taken once a day for 10 or 14 days following twice daily dosing on Day 1.

Table 20: Arithmetic Mean (%CV) of PK Parameters in Serial PK-Evaluable Patients Following Dosing of Posaconazole Injection (300 mg) 300 mg dose administered over 90 minutes once a day following twice daily dosing on Day 1 AUC 0-24 = area under the concentration-time curve over the dosing interval (i.e., 24 hours); C av = time-averaged concentrations (i.e., AUC 0-24h /24hr); C min = POS trough level immediately before a subject received the dose of POS on the day specified in the protocol; C max = observed maximum plasma concentration; CV = coefficient of variation, expressed as a percent (%); Day = study day on treatment; T max = time of observed maximum plasma concentration.

Day N C max (ng/mL) T max Median (minimum-maximum) (hr) AUC 0-24 (ng * hr/mL) C av (ng/mL) C min (ng/mL) 10/14 49 3280 (74) 1.5 (0.98-4.0) 36100 (35) 1500 (35) 1090 (44) Distribution The mean volume of distribution of posaconazole after intravenous solution administration was 261 L and ranged from 226-295 L between studies and dose levels. Posaconazole is highly bound to human plasma proteins (> 98%), predominantly to albumin. Metabolism Posaconazole primarily circulates as the parent compound in plasma.

Of the circulating metabolites, the majority are glucuronide conjugates formed via UDP glucuronidation (phase 2 enzymes). Posaconazole does not have any major circulating oxidative (CYP450 mediated) metabolites. The excreted metabolites in urine and feces account for ~ 17% of the administered radiolabeled dose.

Posaconazole is a substrate for p-glycoprotein (P-gp) efflux. In vitro studies with human hepatic microsomes and clinical studies indicate that posaconazole is an inhibitor primarily of CYP3A4. Excretion Posaconazole injection is eliminated with a mean terminal half-life (t ½ ) of 27 hours and a total body clearance (CL) of

7.3L/h. Specific Populations No clinically significant differences in the pharmacokinetics of posaconazole were observed based on age, sex, renal impairment, and indication (prophylaxis or treatment). Race/Ethnicity In a population pharmacokinetic analysis of posaconazole, AUC was found to be 25% higher in Chinese patients relative to patients from other races/ethnicities.

This higher exposure is not expected to be clinically relevant given the expected variability in posaconazole exposure [see Use in Specific Populations (8.9) ] . Patients Weighing More Than 120 kg Weight has a clinically significant effect on posaconazole clearance. Relative to 70 kg patients, the C avg i… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics 109 words ▾

12.2Pharmacodynamics Exposure Response Relationship: Treatment of Invasive Aspergillosis in Adult and Adolescent Patients Across a range of posaconazole plasma minimum concentrations (C min , range: 244 to 5663 ng/mL) following administration of posaconazole injection and Noxafil delayed-release tablets in adult and pediatric patients aged 14 years and older treated for invasive aspergillosis in Aspergillosis Treatment Study, there was no association between posaconazole C min and treatment efficacy [see Clinical Pharmacology (12.3) and Clinical Studies (14.1) ] .

Similarly, across a range of population pharmacokinetic model-predicted steady-state plasma average concentrations (C avg , range: 589 to 6315 ng/mL), there was no association between posaconazole C avg and treatment efficacy.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Treatment of Invasive Aspergillosis with Posaconazole Injection and Noxafil Delayed-Release Tablets Aspergillosis Treatment Study (NCT01782131) was a randomized, double-blind, controlled trial which evaluated the safety and efficacy of posaconazole injection and Noxafil delayed-release tablets versus voriconazole for primary treatment of invasive fungal disease caused by Aspergillus species. Eligible patients had proven, probable, or possible invasive fungal infections per the European Organization for Research and Treatment of Cancer/Mycoses Study Group, EORTC/MSG criteria.

Patients were stratified by risk for mortality or poor outcome where high risk included a history of allogeneic bone marrow transplant, liver transplant, or relapsed leukemia undergoing salvage chemotherapy. The median age of patients was 57 years (range 14-91 years), with 27.8% of patients aged ≥65 years; 5 patients were pediatric patients 14-16 years of age, of whom 3 were treated with posaconazole and 2 with voriconazole. The majority of patients were male (59.8%) and white (67.1%).

With regard to risk factors for invasive aspergillosis, approximately two-thirds of the patients in the study had a recent history of neutropenia, while approximately 20% with a history of an allogeneic stem cell transplant. Over 80% of subjects in each treatment group had infection limited to the lower respiratory tract (primarily lung), while approximately 11% to 13% also had infection in another organ. Invasive aspergillosis was proven or probable in 58.1% of patients as classified by independent adjudicators blinded to study treatment assignment.

At least one Aspergillus species was identified in 21% of the patients; A. fumigatus and A. flavus were the most common pathogens identified. Patients randomized to receive posaconazole were given a dose of 300 mg once daily (twice daily on Day 1) IV or tablet. Patients randomized to receive voriconazole were given a dose of 6 mg/kg twice daily Day 1 followed by 4 mg/kg twice daily IV, or oral 300 mg twice daily Day 1 followed by 200 mg twice daily.

The recommended initial route of administration was IV; however, patients could begin oral therapy if clinically stable and able to tolerate oral dosing. The transition from IV to oral therapy occurred when the patient was clinically stable. The protocol recommended duration of therapy was 84 days with a maximum allowed duration of 98 days.

Median treatment duration was 67 days for posaconazole patients and 64 days for voriconazole patients. Overall, 55% to 60% of patients began treatment with the IV formulation with a median duration of 9 days for the initial IV dosing. The Intent to Treat (ITT) population included all patients randomized and receiving at least one dose of study treatment.

All-cause mortality through Day 42 in the overall population (ITT) was 15.3% for posaconazole patients compared to 20.6% for voriconazole patients for an adjusted treatment difference of -5.3% with a 95% confidence interval of -11.6 to 1.0%. Consistent results were seen in patients with proven or probable invasive aspergillosis per EORTC criteria (see Table 32). Table 32: Posaconazole Injection and Noxafil Delayed-Release Tablets Invasive Aspergillosis Treatment Study: All-Cause Mortality Through Day 42 Posaconazole Injection and Noxafil Delayed- Release Tablets Voriconazole Population N n (%) N n (%) Difference Adjusted treatment difference based on Miettinen and Nurminen’s method stratified by randomization factor (risk for mortality/poor outcome), using Cochran-Mantel-Haenszel weighting scheme.

(95% CI) Intent to Treat 288 44 (15.3) 287 59 (20.6) -5.3 (-11.6, 1.0) Proven/Probable Invasive Aspergillosis 163 31 (19.0) 171 32 (18.7) 0.3 (-8.2, 8.8) Global clinical response at Week 6 was assessed by a blinded, independent adjudication committee based upon prespecified clinical, radiologic, and mycologic criteria. In the subgroup of patients with proven or probable invasive… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 216 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis No drug-related neoplasms were recorded in rats or mice treated with posaconazole for 2 years at doses higher than the clinical dose. In a 2 year carcinogenicity study, rats were given posaconazole orally at doses up to 20 mg/kg (females), or 30 mg/kg (males). These doses are equivalent to 3.9- or 3.5 times the exposure achieved with a 400 mg twice daily oral suspension regimen, respectively, based on steady-state AUC in healthy volunteers administered a high-fat meal (400 mg twice daily oral suspension regimen).

In the mouse study, mice were treated at oral doses up to 60 mg/kg/day or 4.8 times the exposure achieved with a 400 mg twice daily oral suspension regimen. Mutagenesis Posaconazole was not genotoxic or clastogenic when evaluated in bacterial mutagenicity (Ames), a chromosome aberration study in human peripheral blood lymphocytes, a Chinese hamster ovary cell mutagenicity study, and a mouse bone marrow micronucleus study. Impairment of Fertility Posaconazole had no effect on fertility of male rats at a dose up to 180 mg/kg (1.7 × the 400 mg twice daily oral suspension regimen based on steady-state plasma concentrations in healthy volunteers) or female rats at a dose up to 45 mg/kg (2.2 × the 400 mg twice daily oral suspension regimen).

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 213 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis No drug-related neoplasms were recorded in rats or mice treated with posaconazole for 2 years at doses higher than the clinical dose. In a 2 year carcinogenicity study, rats were given posaconazole orally at doses up to 20 mg/kg (females), or 30 mg/kg (males). These doses are equivalent to 3.9- or 3.5 times the exposure achieved with a 400 mg twice daily oral suspension regimen, respectively, based on steady-state AUC in healthy volunteers administered a high-fat meal (400 mg twice daily oral suspension regimen).

In the mouse study, mice were treated at oral doses up to 60 mg/kg/day or 4.8 times the exposure achieved with a 400 mg twice daily oral suspension regimen. Mutagenesis Posaconazole was not genotoxic or clastogenic when evaluated in bacterial mutagenicity (Ames), a chromosome aberration study in human peripheral blood lymphocytes, a Chinese hamster ovary cell mutagenicity study, and a mouse bone marrow micronucleus study. Impairment of Fertility Posaconazole had no effect on fertility of male rats at a dose up to 180 mg/kg (1.7 × the 400 mg twice daily oral suspension regimen based on steady-state plasma concentrations in healthy volunteers) or female rats at a dose up to 45 mg/kg (2.2 × the 400 mg twice daily oral suspension regimen).

📄 Patient Package Insert ~3 min read ▾

Patient Information Posaconazole Injection (poe" sa kon' a zole) What is posaconazole injection? Posaconazole injection is a prescription medicine used in adults and children to help prevent or treat fungal infections that can spread throughout your body (invasive fungal infections). These infections are caused by fungi called Aspergillus or Candida.

Posaconazole injection is used in people who have an increased chance of getting these infections due to a weak immune system. These include people who have had a hematopoietic stem cell transplantation (bone marrow transplant) with graft versus host disease or those with a low white blood cell count due to chemotherapy for blood cancers (hematologic malignancies). Posaconazole injection is used for: • prevention of fungal infections in adults and children 2 years of age and older who weigh 22 lbs (10 kg) or greater. • treatment of fungal infections in adults and children 2 years of age and older who weigh 22 lbs (10 kg) or greater.

It is not known if posaconazole injection is safe and effective in children under 2 years of age. Do not take posaconazole injection if you: • are allergic to posaconazole, any of the ingredients in posaconazole injection or other azole antifungal medicines. See the end of this Patient Information leaflet for a complete list of ingredients in posaconazole injection. • are taking any of the following medicines: o sirolimus o pimozide o quinidine o certain statin medicines that lower cholesterol (atorvastatin, lovastatin, simvastatin) o ergot alkaloids (ergotamine, dihydroergotamine) • have chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) and you have just started taking venetoclax or your venetoclax dose is being slowly increased.

Ask your healthcare provider or pharmacist if you are not sure if you are taking any of these medicines. Do not start taking a new medicine without talking to your healthcare provider or pharmacist. Before you take posaconazole injection, tell your healthcare provider about all of your medical conditions, including if you: • are taking certain medicines that lower your immune system like cyclosporine or tacrolimus. • are taking certain drugs for HIV infection, such as ritonavir, atazanavir, efavirenz, or fosamprenavir.

Efavirenz and fosamprenavir can cause a decrease in the posaconazole levels in your body. Efavirenz and fosamprenavir should not be taken with posaconazole injection. • are taking midazolam, a hypnotic and sedative medicine. • are taking vincristine, vinblastine and other “vinca alkaloids” (medicines used to treat cancer). • are taking venetoclax, a medicine used to treat cancer. • have or had liver problems. • have or had kidney problems. • have or had an abnormal heart rate or rhythm, heart problems, or blood circulation problems. • are pregnant or plan to become pregnant.

It is not known if posaconazole injection will harm your unborn baby. • are breastfeeding or plan to breastfeed. It is not known if posaconazole passes into your breast milk. You and your healthcare provider should decide if you will take posaconazole injection or breastfeed.

You should not do both. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Posaconazole injection can affect the way other medicines work, and other medicines can affect the way posaconazole injection works, and can cause serious side effects.

Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure. Know the medicines you take. Keep a list of them with you to show your healthcare provider or pharmacist when you get a new medicine.

How should I take posaconazole injection? • Take posaconazole injection exactly as your healthcare provider tells you to take it. • Your healthcare provider will tell you how much posaconazole injection to take and when to take it. • Take posaconazole injection for as long as your heal… [Excerpted — this section continues on DailyMed.]

📄 Recent Major Changes 16 words ▾

Indications and Usage ( 1.1 , 1.2 ) 1/2026 Dosage and Administration ( 2 ) 1/2026

📄 Package Label / Principal Display Panel 171 words ▾

PRINCIPAL DISPLAY PANEL – 300 mg/16.7 mL NDC 67457-665-20 Posaconazole Injection 300 mg/16.7 mL (18 mg/mL) For Intravenous Use Only Requires further dilution prior to infusion. Discard Unused Portion Sterile Mylan Rx only Single-Dose Vial Each vial contains: 300 mg posaconzole/16.7 mL. Each mL contains: 18 mg Inactive ingredients: 6.68 g betadex sulfobutyl either sodium , 0.0033 g edetate disodium, and hyrochloric acid and sodium hydroxide to adjust pH to 2.6.

Usual Dosage: See prescribing information. Read accompanying directions carefully for the preparation of Posaconazole Injection. Posaconazole Injection is a clear, colorless to yellow, sterile injection.

Variations in color within this range do not affect the quality of the product. Stored refrigerated at 2° to 8°C (36° to 46°F). Diluted Posaconazole Injection solution in the intravenous bag (or bottle) if not used immediately, can be stored up to 24 hours refrigerated 2° to 8°C (36° to 46°F).

Manufactured for: Mylan Institutional LLC Morgantown, WV 26505 U.S.A. Manufactured by: Mylan Institutional Galway, Ireland Mylan.com Posaconazole Injection Carton 300 mg/16.7 mL Carton Label

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Posaconazole — the program that covers self-administered drugs. 13 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Posaconazole. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$11.45M
Claims incl. refills
15.2K
Beneficiaries
7.5K
Spend / beneficiary
$1,532.80
Spend / claim
$753.69
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk ✓ Available
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Mylan Institutional LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Mylan Institutional LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J1837 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 67457-0658-10 · Mylan 67457-0675-02 · Mylan →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.